Good day, and thank you for standing by. Welcome to the CPT III Code Language Discussion conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To remove yourself from the queue, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Stephen Schultz, Senior Vice President of Investor Relations. Please go ahead, sir.
Yes. Good day, and welcome, everyone, and thank you for joining us for this program on the newly issued CPT III code language. I'm Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. Before we begin, let me remind everyone that during today's event, the team will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about our commercial plans and potential reimbursement, and our ability to obtain regulatory approval to launch and successfully commercialize COMP360 psilocybin therapy. You should not place undue reliance on these forward-looking statements. Actual events or results could differ materially from those expressed or implied in any forward-looking statements as a result of various risks, uncertainties, and other factors, including those risks and uncertainties described under the heading Risk Factors in our filings with the SEC.
Additionally, these forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement, even if our estimates or assumptions change. Also, please note that the opinions of our guest is theirs and not necessarily that of COMPASS Pathways. At the conclusion of this call, we'll take questions, and at the conclusion of the program, if we are unable to get all the questions in, or you would like a meeting with management, please reach out to me directly. With that, I'm pleased to introduce Kabir Nath, COMPASS Pathways CEO.
Thank you very much, Steve, and let me add my welcome to everyone for joining us for today's webinar on the recently released language of the CPT III code. This code, as you know, is for continuous in-person monitoring and intervention during psychedelic medication therapy. As you know from our recent press release, this code will go into effect and will be published in the CPT manual from January 1st, 2024. You might be surprised and think it's a bit hyperbolic that we describe the creation and approval of something as apparently mundane as a CPT code as exciting. We truly are excited by this development. This code is going to play a crucial role to facilitate reimbursement and support broad and equitable access to psychedelic treatments if they receive regulatory approval.
This is critical for people who are in urgent need of new options for difficult-to-treat serious mental health issues, such as treatment-resistant depression, anorexia nervosa, and post-traumatic stress disorder. We're delighted also to welcome to this discussion today two esteemed guests from both the payer and the provider communities, and I look forward to the discussion. With that, let me now hand over to today's moderator, Chris Williams, our Chief Communications Officer here at COMPASS Pathways. Chris?
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I think we're having a bit of a tech, technical difficulty there. I'll proceed with.
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Well, I hope it's disconnected now. Again, apologies for that. We're having some technical difficulties today, but we want to introduce our panelists. We have Dr. Geoffrey Grammer, Chief Medical Officer at Greenbrook TMS Centers, who represent a provider point of view. I hope we have Dr. Marketa Wills right now, Chief Medical Officer at Johns Hopkins HealthCare, who will offer a payer's perspective on the CPT III code. We've had some technical difficulties getting Marketa connected today, we'll see if she's able to participate as planned. Finally, we have Dr. Steve Levine, our colleague here at COMPASS Pathways, who's Senior Vice President for Patient Access and Medical Affairs.
Let's get into the conversation right away. I think what I better do is start by first putting a question to Steve, since I know I have him here in front of us, and he can hear me. Steve, can you briefly remind us what CPT codes are and what role they play in the delivery of healthcare in the United States?
Thank you, Chris. Yes, I can hear you. CPT codes are a common language for doctors and other healthcare professionals to describe and report medical services and procedures accurately and efficiently to facilitate reimbursement by payers. Essentially, anytime healthcare providers and patients interact, CPT codes are involved.
Great. Thanks, Steve. Jeff, let's go to you. We're curious to get your kind of high-level take on the language of the CPT III code for psychedelic therapies now that it's been released. From your perspective as a provider, why don't you tell us a little bit about what having the CPT code means and how it will create access for a therapy for patients? What does this look like for you in your centers?
I mean, this is a big step because when you're doing a treatment modality that requires observation after administration of a compound or substance, you need to be able to model some method of doing that. You know, the drug is one expense, and that has its own pathway towards coverage. A big piece of that is going to be some sort of compensation for the facility or provider who is overseeing that administration. Without- both of those things satisfied, you can't create the systems needed to deliver the treatment to the patients who need it.
Jeff, let's stay with you. Can you give us a recent example where not having a code that would have this kind of language made it difficult or maybe even impossible for you to deliver an approved therapy because there wasn't any existing code that you could work with?
Yeah, thank you. I mean, it's interesting. Greenbrook TMS has 133 centers around the country, and we sort of specialize in taking treatment modalities and bringing them to the patients who need it. When we think about the barriers to that, I usually think of three things that need to be satisfied. You have to have awareness, you have to have some geographic proximity to be able to access that modality. That's why we have centers in a lot of places. The third piece is the fiscal viability. The reality is, you know, most patients who would need this treatment cannot afford sort of a fee-for-service, cash-only model, and it keeps them financially separated from that treatment.
If we go back to both TMS, which is transcranial magnetic stimulation, and Spravato, you know, we saw launches for both of those that were, in a way, stagnated, probably worse with TMS, because all those things weren't necessarily satisfied. It was unclear where they were gonna kind of deploy these devices, who's going to be doing the treatment delivery, and how those would be coded and billed. You know, without that CPT code, you can't begin to even talk with payers to come up with a model for compensation that makes this sort of viable, if you will. You know, with Spravato as well, we saw trying to take existing codes and match it to what was a very unique treatment, and it took a while to kind of figure that out.
By doing this on the front end and making it specific for this treatment modality, I think, one, it speaks to just how revolutionary this is going to be, and two, it allows you to do that prep work so that when or if you have approval on launch day one, you already have all those systems in place that people then don't have to invent for the first time. It's going to accelerate the deployment and the adoption of this much more quickly than I think we have seen with other novel treatment modalities.
Great, Jeff. Thank you. Thank you for that. Marketa, are you on the line now? Seems as though we don't have Marketa. Still having some technical challenges there. We apologize for that. Let me build off of what we just heard from Jeff and turn to Kabir and Steve. Steve, we'll start with you as our formal panelist. Can you talk a little bit about the COMPASS perspective on this, then? Looking ahead to a potential commercial launch for us in COMP360 psilocybin treatment, you know, why is this code important for us?
Yeah, thanks, Chris, I hope I'm still connected, and you can still hear me.
Yep, I still got you.
Terrific. Good. We're focused patient access for those who may benefit from COMP360 psilocybin therapy, if approved. Among several factors in creating that access, the delivery of the psychological support must be financially viable for healthcare providers. This is a critical step for patient access and commercially, and really a proof point that this is possible.
Kabir, anything you wanna add to that?
No, I think what I would add is also, I think, what's really important is what Jeff noted, which is doing this work so far in advance is really enabling us to be in a place where the infrastructure, the ability to actually deploy this code and ultimately potentially have it as a reimbursable code by the time a launch is really, really important. Again, I think it's a great example of where, as we say, at COMPASS, we've designed things from kind of the end state back to make sure we're ready for that commercialization if we are indeed approved.
Great. Thank you, Kabir. Let me try again to see if we have Marketa.
Can you hear me?
We can hear you. Hello, Marketa.
Hello. Hello, good morning.
Welcome. Welcome to what has so far been a fairly glitchy conversation, which is no fault of yours. We're glad that we're able to finally get you into the conversation, and just in the nick of time, as I have, I have a couple questions for you. If you're ready, I'm going to fire away.
I am ready. Thanks so much for having me on this morning.
Great. Let's I'm gonna throw to you the same question that I started off with on with Jeff, which is to just get your perspective at a high level about the approval of the CPT III code for the administration of psychedelic treatments. You know, what's your reaction to it? Maybe you could also tell us a little bit about when you see a code like this, a new code, what is it that you're looking for, and what are you looking to track?
Yes. Thank you so much for the question and the backdrop. Here, in sort of the plan setting, when new codes are released, particularly the CPT III codes, we have a team of folks who really go in and comb through the literature, the evidence, to really understand how to price the codes and how to apply the codes in the managed care setting. Our main touch competitive landscape touch point is often CMS and Medicare. We keep a close eye on the competitive landscape around codes and pricing.
As new CPT III codes emerge, we're often eagerly anticipating how we will process through investigational, experimental, and yet to be released modalities against all of our other offerings from the plan.
Great. Thanks very much, Marketa. Maybe if you could pick up on this theme of, you know, kind of flexibility and granularity in the code, you know, what does that facilitate for a payer?
As we think about what all is included in the code, whether or not services are bundled or disaggregated, it allows us to more appropriately price for the services under consideration. To the degree that various pieces can be bundled or pulled out, it allows us to really think through alternatives versus alternatives to treatment. I think another important point in this particular offering that we're excited about is that we know that treatment-resistant depression really impacts the degree to which other physical health modalities are addressed, and physical health conditions are addressed and taken care of.
Our numbers show us over and over again that if someone has treatment-resistant depression, and has, for example, a cardiac condition, the costs are going to be much more. When we think about the actuarial consideration around pricing, we take into account the total cost of care. We are very excited about this coming forward to the benefit of our membership.
Marketa, let me ask you a follow-up question. I want to pick up, I think, on something that we heard from Jeffrey earlier, who talked through a little bit about the challenge of trying to administer some of these treatments when there wasn't a CPT code in place to clearly facilitate that. Is that a challenge from a payer perspective as well, or has that been a challenge from a payer perspective as well?
Oh, certainly. Almost to the point where we're not really able to reimburse when there's no CPT code. CPT codes are certainly sort of the gold standard by which we think through our, what we call internally, our source of truth on how we Our payment strategy across all of our lines of business. Without ICD-9, 10, or 11 codes, as well as CPT codes, we're just not able to do that. It really is a critical enabler for us to be able to move forward with our plan offerings.
... Great. Thank you very much for that. We, we've got a number of people on the line who I think probably are gonna wanna ask some questions as well. I think we'll wrap up the moderated discussion here. But before I turn it back over to Stephen Schultz, for his bringing in the analyst questions, and Kabir for some closing thoughts. I just wanna ask Jeff, Marketa, if you have any closing thoughts as we wrap up this portion of our program today. Jeff, why don't we, why don't we start with you? I think Jeff maybe is having trouble hearing me.
Can you guys hear me?
Yep. Yep, got you there.
All right, good. Sorry about that. It wouldn't let me unmute.
We got you.
Yeah, what I would say is this: I mean, this is exciting, right? We're seeing the field of psychiatry change or behavioral health change pretty substantially. The era of psychotherapy and medications being the base of all treatment is beginning to evolve into something much more sophisticated. I equate it to the difference between office-based cardiology and interventional cardiology. The two need to work hand in hand together to be able to, you know, better help their patients. You know, companies like Greenbrook are trying to fill that need. With this evolution, what it allows us to do is begin to build in the systems and processes now in our company at Greenbrook. Literally, the facilities, the logistics, the staffing, the modeling, putting the financial models together to figure out how to get this to the patients who need it.
If we look at the need for treatment-resistant depression, we are talking millions of patients. One third of people who get treated with medications and/or therapy will not have an adequate recovery. You're talking prevalence rates of depression in the U.S. being between, depending on which stat you look at, 7% up to almost 20% during the pandemic. You are talking a huge number of people with needs, and we now are in a position where we don't have to wait for approval and launch to begin to build the systems. We can do it today, so that when the time does come, we can help those patients who are seeking out this therapy.
Jeff, thanks very much. Marketa, any closing thoughts from you before I hand to Kabir?
Yeah, thanks for that opportunity. I'd echo the previous panelists' comments. This is a game changer for the field of psychiatry. It will allow us to think differently about how we think of total cost of care for physical health and behavioral health interventions. I'm, for one, am excited about this opening up. I'm excited about access for all communities, whether they be low-income communities in Medicaid or Medicare, commercial populations as well. I think that this modality is gonna be certainly a game changer that unlocks treatment for folks who were having limitations being treated with medications and therapy.
Marketa, thank you. Jeff, Marketa, thanks to both of you for joining us in our conversation today. I'll ask that you stay with us for the Q&A portion of today's program. Let me ask Kabir for some closing comments before we take it back to Steve Schultz. Oh, Kabir, I don't think we've got your audio. I can't hear Kabir. Kabir, you want to give it one more shot?
Yes. Can you hear me now?
We got you.
Can you hear me now? All right.
Yes.
Sorry about that. Thank you very much to Jeff and Marketa for joining us. I think just a couple of salient points to pick up. I think you used words like revolutionary and game changing, and that's certainly how we see the potential for psychedelic therapies if they're approved. I think the other thing was, you know, thank you again to both of you for reminding us of the urgent need here, the unmet need. Certainly, the prevalence of treatment-resistant depression, the fact that so many people with depression will unfortunately progress to not being served well by current treatments, and also the extensive comorbidities, that this is not just a disease that you can see in isolation. Again, as I said at the start, we truly are excited.
I'm proud of the fact that we, together with MAPS PBC, led this work in a very early way in order to allow folks like Jeff and indeed Marketa, to do the work in their different institutions that prepares for the potential approval and launch of these. Again, very excited about it. I think, you know, another key example of the building blocks we at COMPASS are putting in place for success in the long run.
Thanks, Kabir. I'm told that Steve Schultz is with us, even though I can't see him. Steve, if you're there-
I'm all on. Can you hear me, Chris?
Yeah, we got you, Steve. Great, thanks. Glad to hear you. Let's.
I think-
Let's turn over to you for the Q&A.
All right, good. Thank you. I apologize for not being on video, but I'm sure all of you have seen enough of me. Let me begin with questions. I will start with Patrick Trucchio of H.C. Wainwright & Co. Patrick, go ahead, please.
Thanks. Hi, good morning, congrats on getting the Category III CPT code through the system well in advance of the substantial launch of COMP360. If we look ahead, post-approval, Compass would still need a Category I CPT code, which could take 1-3 years to receive. Our understanding is that having this Category III CPT code may accelerate the timing. For the panel, a few questions. First, is this understanding of this transition from the Category III to Category I CPT codes correct? Secondly, can you discuss how you would go from having a Category III CPT code to a Category I CPT code? What is the difference between these codes?
Ultimately, you know, how do you, how do you accelerate it, you know, from maybe what was seen with Spravato or TMS or some of these other examples, how do you accelerate that timing? Ultimately, how much does having this Category III CPT code now accelerate this launch for COMP360, you know, assuming it's approved in a few years?
Is that one I should take?
Yep.
How are we going to-
Steve, why don't you start? Yep.
Great. Yeah, happy to start there. Thank you. That's a great question, Patrick. I think, you know, this partly relates back to something that Jeff was touching on earlier. This was around the urgent need that exists right now for these patients, the work that needs to be done in order to create this access, and the fact that a lot of that work can start now, even ahead of approval. This is a perfect example of that. You know, there is no access without FDA approval. Let's just start there, right? There is no shortcut to that. We are committed to the rigor of conducting the studies that will get us to that approval.
At the same time, I think we need to have some confidence in the likelihood of that approval, and with that, to begin all the work that we can do now, rather than waiting until approval and therefore having delays potentially to patient access. This is a perfect example of that. By applying for and receiving the Category III codes now, we can start that clock earlier on that required time. Patrick, as you mentioned, that often can be 1 to 3 years, post the issuance of a Category III code or post the approval of a product.
One of the criteria for moving from Category III to Category I is sufficient reporting of that code and usage of that code in the community, so that healthcare providers can be surveyed as to the work being done to deliver these services, and a value can be applied to the code when it's issued. In the case of this code that's just been approved, it's 0820T. It is not specific to our product or to any particular indication. It can be used across a range of product services and indications. Early applications of this code may be to ketamine-assisted therapy, or should MAPS have their product approved for PTSD, which, you know, may come before us, this code will already start to be used.
Because there's, you know, likely a few years prior to our potential approval and launch, there is likely to be sufficient usage of this code such that we can more quickly move towards that Category I code and potentially even prior to our launch.
Got it. I think in the past, you've talked about the need for education initiatives to make sure service providers are aware of the code's existence and its eventual use with psychedelic therapeutics. My question for the panel is: You know, what are the best ways to make service providers aware of the Category III CPT code's existence?
I don't know if Jeff or Marketa, you want to weigh in on that, please? That would be great to get your perspectives.
Yeah, I... Can you guys still hear me okay?
Yeah, we can.
Okay, good. Sorry. The mute button on the on the software here is not indicating on or off, so I'm never sure what status I'm in. So I actually don't think that when that launches, that's going to be as big of an issue in the psychedelic community for a couple of reasons, right? Honestly, when there's a new modality that comes out like this, you're going to have service providers who are basically like: You know, what are the methods by which we're supposed to communicate with payers on this? It's like, well, here's the code for this individual modality. You know, I'm not going to speak to COMPASS's launch, but I'm sure it's not going to come without its own fair, robust, outreach to improve awareness within the medical community and with patients.
When companies do that, they typically will fold in this information when it's relevant to that particular modality. Yeah, I honestly think the uptake on that, of all the things we're going to have to worry about, that at least on the service provider side, that's probably going to be much less of a hurdle than other things.
Thanks, Jeff.
Jumping in, certainly, professional organizations such as the American Psychiatric Association, American Psychological Association, are as well as MAPS.
... the group focused on psychedelic drugs, work with provider community to sort of prime them for as new technologies and things emerge. I think those kinds of professional society organizations are well poised to help sort of get the word out and get providers notified and educated. I think that's an important piece of that, too. Obviously, training and trainees will need to be a part of that as well. Thank you.
Thanks very much, Marketa. Thanks, Patrick, for the questions. I think, Steve, we can move on.
Absolutely. Thank you, Patrick. The next question comes from Neena Bitritto-Garg of Citi. Neena, go ahead, please.
It's Avi on the line for Neena. Thank you for taking me. I was sort of wondering, does the code cover, I guess, if there are multiple patients going through therapy at the same time, could the code cover all of them that the physician could only report one hour if they're if they're monitoring multiple patients? Or could they, in theory, report the code for each patient? In addition, does this also include the integration session or just the dosing? Thank you.
Thanks, Steve, if you could take those, please.
Yep, that sounds like one for me. As a reminder, this therapy is delivered in three components: the preparation sessions, an administration day, and then integration sessions. The administration day being the only one where there is drug involved. Preparation and integration sessions, even though our model is not psychotherapy, are covered by existing psychotherapy codes. The gap that this new code is addressing is the psychological support delivered on the day of administration, and that psychological support code, our new code, does not preclude also reporting a medical code and an evaluation management code on the same day. This code, initially, the first code itself describes one therapist in the room with the patient providing that support, and the two subcodes allow for a second healthcare provider in the room or the involvement of clinical staff.
To your question, this code does allow for simultaneous administration to multiple patients. A scenario that would be covered by this code is multiple patients being treated simultaneously with a appropriate therapist in the room, with each patient, with a physician or other appropriate prescriber supervising, who's available. You know, as you can see with this, along with the ability to report this on an hour-by-hour basis, there really is a lot of granularity involved in the reporting here to allow for a number of different scenarios, including simultaneous administration.
Thanks, Steve. Thanks for the question.
Thank you.
Yes, thank you. The next question comes from François Brisebois, from Oppenheimer. Frank, go ahead, please.
Hi, can you guys hear me okay?
Yep.
We sure can. Yes.
Okay. Great. I was just wondering, is the timing surprising here of this approval, or has there been precedence in this field of psychiatry, where this has happened so early in advance? Thanks. Maybe I'll just loop in the second one quick, is I was just wondering, in terms of the FDA guidance that came out recently, I was just wondering if you guys wanted to comment on, you know, what you thought it could mean for COMPASS. You know, would it help actually for this coding if someone else, like MAPS, was approved earlier? How does the guidance maybe affect MAPS? I don't know if you're willing to comment on any of those. Thank you.
Thanks, Frank. Jeff, perhaps if I could ask you, because I think you commented on, you know, how doing this early in this case is very valuable, but you can give your perspective on some other innovations in psychiatry and whether this has happened before.
to my knowledge, I mean, I think this is actually unique, and I think it's unique, honestly. I think it's from a couple of things. I think, number 1, it talks about the paradigm shift that we're seeing in psychiatry, where we're shifting off from kind of traditional things into interventional psychiatry and in particular, this emerging role of psychedelics. That's incredibly refreshing. That's unique. That hasn't happened. I mean, if we look back in the world of psychiatry, we had medicine therapy and ECT for a number of years, it was really TMS therapy that came along that was sort of the first into this interventional psychiatry on any kind of large-scale basis. That then moved into into Spravato or nasal esketamine as the next.
It seems to me like what's happening, I'm not in the inner room with COMPASS Pathways at all, but what I think what's happening is they had the wisdom to look back at those launches and said, "Well, what can we learn from this?" I think the field of psychedelic therapy also has done the same thing. I think this is unique and that it's being done early. I think it is the right answer, and I think it's because of the lessons learned from other launches.
Thanks for that, Jeff. It the second part of the question, I mean, as you're aware, this work was undertaken in collaboration with MAPS PBC. While I obviously can't comment on their strategy or their plans or, you know, their regulatory strategy or anything else. Certainly from a use of the code, I mean, we would expect MAPS PBC to be doing so, should they be approved. Steve, I don't know if there's anything you want to add on that?
Just the extension, which is that, you know, should they receive approval and launch prior to us, their usage of that code is very favorable to us and to the field. It does help to start to establish the tracking of the use of the code and move it along towards the conversion to Category I.
Thanks. Thank you, Frank.
Oh, can you still hear me?
Yes.
I was just wondering if you wanted to comment on the FDA guidance for psychedelic drug development that came out recently, and if there's any impact here?
Sure. No, I mean, I think what we have said is that we were not surprised by anything in that. It was very much aligned with what we already understood of the agency's thinking. In fact, if you drill into it, their description of what would be an acceptable phase 3 program, well, you'll find very much describes the COMPASS phase 3 program. No, we don't see any need to make any changes to our trial designs and so on. Finally, we're actually delighted to see those guidelines out. I think they're actually a significant advance for the full sector and a sign of the FDA's, you know, very deep engagement with this sector, recognizing the complexities.
Just as a reminder, of course, we have been in dialogue with the FDA around COMP360 for close to six or seven years by this stage.
Thank you.
Thank you, Frank. Next question comes from Elemer Piros of EF Hutton. Elemer, please.
Good afternoon. This question... Can you hear me?
Yes, we can.
We sure can, yes.
Yes. Sorry. This question may be best addressed to Marketa. Marketa, you mentioned that you would look at a number of factors when figuring out how to price the code. Whether it's psilocybin therapy or MDMA therapy, the administration, the support is certainly more unique or different than administering Spravato or TMS. What sort of factors would go into your pricing decisions there?
Yes, thank you for that. I think the amount of training required for the therapists who would support the administration of the drug, the duration of therapy needed, so the time, what would be part of that, the number of therapists needed at any given time. All of those factors would be weighed against the traditional psychotherapy codes and taken a look at. You know, we'd make sort of the actuarial determination. We do, as I stated before, look broadly across the marketplace as well when we're making those decisions. That's sort of the approach that we take.
Those would be some of the factors that would go in to the therapeutic component of it.
Hmm. Thank you very much, Marketa.
Thanks, Elemer.
Thank you, Elemer. The next question comes from that of Charles Duncan of Cantor Fitzgerald. Charles?
Stephen, can you hear me?
Yes, we can. Thank you.
Okay, super. Kabir and team, thanks for hosting this webinar. To the two KOLs, Jeff and Marketa, I had a question for you. When you think about the, I guess, the therapeutic utility of, say, COMP360s and potential barriers to adoption, now that the CPT III codes are articulated, I guess I'm wondering: What do you think is the greatest risk in the development of COMP360? Is it, is it clinical execution and/or data, such as effect sizes? Is it regulatory, or are there other nuances in commercialization, such as, you know, availability of therapists that makes you wonder about the potential therapeutic utility of the paradigm?
Thanks, Charles. If I can ask Marketa to go first, and then for Jeff, please.
I think many of the factors that you hit on are. I think of as the risks. Certainly, in the mental health field, there is a well-known, well-documented workforce shortage. I think that's changing. I think with the pandemic, one of the things that happened was that mental health and behavioral health became more accessible and understandable to more people. Over time, we see more and more students moving towards therapy and psychiatry as a field. That's exciting, I think, for all of us, that mental health has certainly emerged.
As sort of no longer the stepsister in medicine, but a driver that I think we're all sort of now intuitively aware of, and so that's exciting. I think while we may have workforce considerations in the short term, in the medium to longer term, I do believe that we're going to see that pipeline grow. Then, of course, the, you know, the regulatory concerns. That being said, I think those are being worked through right now. That's going to always be a risk for all medications that are coming off of the scheduled drug list. That's being worked through right now through the research spearheaded by COMPASS and others.
Those I would identify as the two biggest barriers, but a risk, but as I stated, I do think that I see a path, a very quick path, towards mitigation factors for us as a nation. I'll turn it over.
Okay.
Yes.
Yeah.
I'll follow on that. I think, you know, I look at the two biggest issues, you've already touched on the first, which is: How do you scale this in a way that makes it accessible to the millions of people that need it, right?
Mm-hmm.
That's where I think companies like Greenbrook, that specialize in interventional psychiatry, are going to be a real key in beginning to develop those clinical care models, including things like staffing, a facility, everything else. Again, one nice thing about Spravato already being in the marketplace is it allows for literally brick-and-mortar, you know, renovations to. That we can then extrapolate into, hopefully, the psychedelic marketplace. At least that's how we're approaching it. The other thing, too, is diversion out of the classic medical field. If I saw any risk to the psychedelic community, it's going to be that some people may look to the illicit market to try to achieve the same thing easier and cheaper. There are real problems with that involved in things like purity, dosing, safety, supervision, integration therapy, and so forth.
Certainly, I will tell you, in my own practice, I've seen people try to go that route, and I cannot think of one where that ended up being a durable, favorable benefit for them. The rigor by which companies are investigating and clarifying these models, I think is going to distinctly differentiate it from the amateur, casual, consumers of illicitly acquired substances. In other words, it kind of just doesn't work, is what I'm seeing, if you don't do it right in a medical setting, never mind the safety associated with that.
you know, if we can't build it out, though, I mean, if we can't do what we're doing today and scale this so that someone can call up a center and within a very short period of time, get in and get treated, then what I think could happen is that person, in their desperation to achieve relief, is going to go find a dealer down, you know, someplace and try to do it on the cheap, and that there's all kinds of risks associated with that. Our mission is to make sure that that doesn't happen.
Thanks, Trevor.
Very helpful.
Thanks. Sorry, Charles, go ahead.
A very helpful perspective. Thanks. Thanks, Kabir. One last question for you, which you probably won't answer, but can you provide any additional color on enrollment progress for phase III, or is that something to be discussed in the future? Thanks.
Thanks, Charles. We're on track. Welcome to London, and I look forward to seeing you later this week.
Very good. Thank you.
Thank you, Charles. Appreciate it. The next question comes from Tom Shrader of BTIG. Tom, please go ahead.
Relatively new for a lot of us. Can you talk about how the codes will anticipate? Do I have a terrible echo?
No, it's fine.
Okay, go on. Can you talk about how the codes will anticipate regional variations in cost and billing, which right now in this field are enormous? Also, do you expect the... I understand these are early codes. Do you expect the final codes to prescribe a specific treatment paradigm to help enforce the idea that patients need to go to all the sessions?
Thanks, Tom. Steve, if I can ask you to start on that, but then I'll also invite our guests if they want to jump in on either part of that. Steve, if I can ask you to start, please.
Yeah. Thanks, Kabir. Good questions. I'll take them in reverse order, with the second part, about, you know, will the codes, as they evolve, require patients to have all parts of a treatment? This code, as a reminder, is specific to the administration day. Existing codes will cover preparation and integration sessions. This code is also not specific to any one program, one compound, one indication. It's flexible enough. There's a lot of granularity in the wording of it. It's also flexible enough that it can be used across a range of psychological support models that will fit a given program. You know, with that, there's nothing about the code itself that in any way dictates how it's admin is delivered.
As to regional differences in the valuation of the Category III code itself isn't valued. Category I will be. You know, the main way that that code gets valued, and Marketa touched on this a bit earlier, is through a process with CMS that sets that initial valuation that's based upon some surveying of healthcare providers to understand the work and the resources involved in delivering the therapy. Within CMS, there is, you know, an average national price, but there is a lot of variability regionally that's determined by, you know, various formula that reflect the economics of smaller regions. This tends to be reflected also in the commercial landscape, with variability in reimbursements across regions.
It's not specific to how a code is worded or anything about the code itself, so much as how payers price that code.
Yeah. I don't know that I have much to add to that. This is Marketa. Well stated. You know, again, it just starts with Medicare first. They typically, really look towards the provider to begin to price. Then we, as plans, who support either CMS pricing or commercial pricing afterwards, or Medicaid, will do an actuarial analysis based on that can differ by region.
Yeah, I don't have much to add to any of those comments. What I would say, I think the second half of that was sort of, you know, can the codes help enforce compliance? It's kind of interesting in the world of interventional psychiatry because we're really seeing a remarkably high level of compliance with treatment modalities, and I suspect the same will be within the psychedelic community. If we think about reasons for non-compliance in the treatment-resistant space, the number one reason that, you know, we see in studies like STAR*D and so forth, are gonna be lack of efficacy and then, you know, followed by intolerance, right? You know, these are treatments that truly are a progression in the way that we're treating these diseases, and they tend to be well tolerated, efficacious, at least we think, we hope.
That enhances compliance. If we look at things like TMS therapy and Spravato, I will tell you, both our own internal data and data from manufacturers shows that compliance with those modalities is really high. It makes sense. You know, if you have to take a medication every single day for the rest of your life, and it's causing sexual side effects and weight gain, you may not want to do that. When you have a true alternative that is better tolerated and more efficacious, particularly in the TRD space, I don't think we're gonna have to convince patients to stick with it. In the end, what patients are seeking out is relief from their symptoms, and that's gonna motivate them more than anything else.
Thanks very much, Jeff. Marketa, Steve. Thanks, Thomas Westminster.
Thank you. The next question comes from Sumant Kulkarni of Canaccord Genuity. Sumant, please go ahead.
Thanks for hosting this informative event and for taking my questions. Clearly, it's a major achievement to have a CPT III code so early in this process, but how closely does your administration of COMP360 in your phase 3 program conform to the reimbursable aspects of this code? Are there any elements of your future pivotal programs you might need to tweak to be able to most closely align with this code?
Thanks, Sumant, for that question, and I'll ask Steve to take that, please.
Yeah, it's a great question, Sumant. You know, by design, the writing, the language of this code is built to work for programs that are in development now, but to be a bit future-proofed against additional compounds or indications in the future. It can be reported an hour at a time, so there isn't a base number of hours necessarily, at least in its Category III form. The description of the support during that administration day covers a range of possible interventions, leading from, you know, more passive monitoring through crisis intervention.
This, you know, this is a code that is purpose-built to be widely applicable, not just to COMP360 for treatment-resistant depression or MAPS's assisted therapy for PTSD with MDMA, but a range of possible compounds and other indications that could be explored in the future.
Thank you.
Thank you. With that, we have reached the top of the hour and the end of our program. Thank you, all, for joining. I'll hand now the call back to Kabir for final comments.
Thank you very much, Steve. First of all, thanks to Dr. Marketa Wills and Dr. Geoffrey Grammer for joining us. Thank you for lending your perspectives on this very important development. Thank you to Steve Levine as well, our own in-house expert on all this. Thank you to all of you who attended. Apologies again for the slight delay and some of the technical glitches, we look forward over time to keeping you acquainted with developments in this and really showing you the evidence of how, in parallel with pursuing our phase 3 program, which is clearly on critical track, we are building core elements towards successful commercialization, launch, and the ability to help patients at scale should COMP360 psilocybin therapy be approved. Thank you, everyone. Have a very good rest of the day, wherever you may be. Thank you.
This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.